Beacon Hill Medical Pharmacy Recalls Ascorbic Acid Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Ascorbic Acid 500 mg/mL injectable products due to FDA inspectional findings regarding sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or death if administered.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions, is recalling Ascorbic Acid (Corn Source) 500 mg/mL Injectable, all configurations, for intravenous and subcutaneous use. The recall is being conducted due to a lack of assurance of sterility.
The FDA conducted an inspection that resulted in findings concerning quality control procedures that impacted sterility assurance. The agency has classified this recall as Class II. The affected products were distributed nationwide in the United States.
Patients and healthcare providers should stop using the recalled products and contact their pharmacist or physician for guidance on alternative treatments or further instructions.
The recalled product
- Product
- ASCORBIC ACID (CORN SOURCE) 500 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
- Category
- Drug — Injectable Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 02202013@9 and 04052013@2
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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